"... Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."
National Library of Medicine (NLM) has launched a new feature on its DailyMed website: the Product Identification System. NLM utilizes the data in the SPL documents with images of products which they have on file. For instance, if you type in a color such as "blue," one will find all of the products which have the color blue that are described in SPL documents on DailyMed. If one were to scroll down the web page, one will notice that there are some images of the products which NLM already had on file. Hovering the computer mouse cursor over the image will render a larger version of the images. Double-clicking on the image takes you to the SPL document.
FDA instituted the Drug Listing Act of 1972, this regulatory policy is in the 21 Code of Federal Regulations (CFR) Part 207.
The 21 CFR Part 207 addresses definitions, drug registration requirements, and drug listing requirements by FDA.
Drug Listing information is available publicly on the NDC Directory
A list of registration and listing requirements for the manufacture or distribution of human pharmaceuticals (What establishments need to list) is located here.
Validation rules have been drafted for electronic submission of Drug Listings.
SPL Process, Drug Listing, and Establishment Registration
Important Note: Please join wikispaces (it's free!) so that you can participate in discussions.
*Drug Listing and Establishment Registration Guidance Document*
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
"... Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted."Product Identification System Accessible from DailyMed
National Library of Medicine (NLM) has launched a new feature on its DailyMed website: the Product Identification System. NLM utilizes the data in the SPL documents with images of products which they have on file. For instance, if you type in a color such as "blue," one will find all of the products which have the color blue that are described in SPL documents on DailyMed. If one were to scroll down the web page, one will notice that there are some images of the products which NLM already had on file. Hovering the computer mouse cursor over the image will render a larger version of the images. Double-clicking on the image takes you to the SPL document.
FDA instituted the Drug Listing Act of 1972, this regulatory policy is in the 21 Code of Federal Regulations (CFR) Part 207.
The 21 CFR Part 207 addresses definitions, drug registration requirements, and drug listing requirements by FDA.
Drug Listing information is available publicly on the NDC Directory
Drug Firm Annual Registration Status Database is on the http://www.fda.gov/cder/dfars/docs/querydrls.htm
Current Drug Registration and Listing Instructions are located at http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM162027.pdf
A list of registration and listing requirements for the manufacture or distribution of human pharmaceuticals (What establishments need to list) is located here.
Validation rules have been drafted for electronic submission of Drug Listings.
Special Q&As Sessions:
Jan 2012 - Additional questions: 201201 Additional Q&A from DRLS.pdf(including new CDER data rule linking establishments and NDC product code)
Dec 2011 - Q&A with DRLS 20111207 minutes Q&A DRLS.pdf
Nov 2011 - Update with Dun and Bradstreet: 20111109 Minutes of Update session with D&B.pdf
Mar 2011 - Q&A with DRLS and Import Group: 20110330 Min DRLS Import CMV.pdf
Drug Listing Terminology is here
Drug Listing Q&A is here
DUNS Q&A is here
Drug Listing Scenarios
Q&A [July 2010] with the FDA's Drug Registration and Listing Group here
Drug Listing and Electronic Registration Working Group
Contact any of the Co-Leaders to join this group.Objective: Address questions and concerns regarding SPL that affect the pharma industry.Co-Leaders: Ben Harpster (GSK) and Herbert O'Brien (Bayer)
Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2017: October 4 and 18, November 1, 15, and 29, December 13 and 27
2018 Meeting minutes
2017 Meeting minutes
2016 Meeting minutes
2015 Meeting minutes
2014 Meeting minutes
2013 Meeting minutes
2012 Meeting minutes
2010
2011
2011_01_19 ER-DL Mtg Minutes.pdf
2011_02_02 ER-DL Mtg Minutes.pdf
2011_02_16 ER-DL Mtg Minutes.pdf